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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameTHINPREP 2000 SYSTEM
Classification Nameprocessor, cervical cytology slide, automated
Generic Namecytology slide preparation device
ApplicantCYTYC CORP.
PMA NumberP950039
Supplement NumberS016
Date Received07/22/2005
Decision Date01/18/2006
Product Code
MKQ[ Registered Establishments with MKQ ]
Advisory Committee Hematology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for additional claims to the current labeling. The additional claims consist of extension of the expiration date of the preservcyt sample vials to six weeks, reprocessing "unsatisfactory for evaluation" slides with a cytolyt solution and glacial acetic acid wash, and reference to the gen-probe aptima assays for the detection of chlamydia trachomatis and neisseria gonorrhoeae.
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